EUCTR2010-019522-13-BG进行中（未招募）1 期
A randomized, controlled, double-blind Phase III trial to compare theefficacy, safety and pharmacokinetics of GP2013 plus Cyclophosphamide,Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine,Prednisone, followed by GP2013 or MabThera® maintenance therapy inpatients with previously untreated, advanced stage follicular lymphoma.
HEXAL AG (a Sandoz company)0 个研究点目标入组 618 人开始时间: 2011年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 618
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to meet all of the
- •following criteria:
- •1. Patient with previously untreated advanced stage, CD20-positive FL:
- •a. Ann Arbor classification stage III/IV;
- •b. WHO histologic grade 1, 2 or 3a, as confirmed by central
- •pathological testing; and
- •c. Require therapy for FL as per local guidelines or in the opinion of
- •the treating physician.
- •2. Patient age = 18 years.
- •3. Patient with at least one measurable lesion (accurately measurable in
- •at least 2 perpendicular dimensions);
- •a. at least 1 measurable nodal lesion > 20 mm in the long axis; OR
- •b. at least 1 measurable extranodal lesion with both long and short
- •axes = 10 mm.
- •4. Patient with ECOG performance status 0, 1 or 2.
- •5. Patient with adequate cardiac function defined as cardiac ejection
- •fraction = 45% as measured by ECHO or MUGA, without clinically
- •significant abnormalities.
- •6. Patient with the following laboratory values obtained during
- •Screening (up to 28 days before randomization):
- •a. hemoglobin = 10g/dL (unless abnormalities are due to
- •histologically proven bone marrow involvement by lymphoma);
- •b. absolute neutrophil count (ANC) = 1.5 x 10^9/L (unless
- •abnormalities are due to histologically proven bone marrow involvement
- •by lymphoma);
- •c. platelet count = 100 x 10^9/L (unless abnormalities are due to
- •histologically proven bone marrow involvement by lymphoma);
- •d. total bilirubin < 1.5 x ULN (upper limit of normal) (if Gilbert-
- •Meulengracht syndrome is present, up to 2.0 x ULN is allowed);
- •e. transaminases < 2.5 x ULN;
- •f. serum creatinine level < 2 x ULN or calculated creatinine clearance
- •> 50 mL/min;
- •g. negative serologic or virologic markers for active or latent hepatitis
- •B and hepatitis C infections.
- •7. Sexually active males who accept to use a condom during intercourse
- •while taking the drug and for 12 months after stopping treatment as
- •they should not father a child in this period. A condom is required to be
- •used also by vasectomised men (as well as during intercourse with a
- •male partner) in order to prevent delivery of the drug via seminal fluid.
- •8. a) Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, including women whose
- •career, lifestyle, or sexual orientation precludes intercourse with a male
- •partner and women whose partner have been sterilized by vasectomy or
- •other means, who accept to use a highly effective method of birth
- •control while taking study drug and for 12 months after stopping
- •b) Women who are considered post-menopausal and not of child bearing
- •potential i.e. if they have had 6 months of natural (spontaneous)
- •amenorrhea with an appropriate clinical profile (e.g. age appropriate,
- •history of vasomotor symptoms) or have had surgical bilateral
- •oophorectomy (with or without hysterectomy) or tubal ligation at least
- 另有 11 项未显示
排除标准
- •Patients eligible for this study must not meet any of the following
- •1. Patient with Grade 3b (aggressive) FL or any histology other than FL
- •grade 1, 2 or 3a.
- •2. Patient with histological evidence of transformation to high grade or
- •diffuse large B-cell lymphoma.
- •3. Patient who has previously received any prior therapy for lymphoma
- •e.g. cytostatic or cytotoxic agents, radiotherapy, antibodies, antilymphoma
- •vaccination, experimental treatments and radiotherapy, except who
- •received involved field radiation 4 weeks prior to Cycle 1 Day 1, of up to
- •two lesions that will not be used to evaluate disease progression.
- •4. Evidence of significant leukemic disease defined as >10 x 109 /L
- •circulating CD20+ lymphoma cells.
- •5. Patient with clinical evidence of central nervous system (CNS)
- •involvement by lymphoma or any evidence of spinal cord compression by
- •6. Patient with evidence of any uncontrolled, acute or chronic active
- •infection (viral, bacterial, including tuberculosis or fungal).
- •7. Patient receiving chronic (>3 months), high dose (> 20 mg of
- •prednisone or > approximately 3 mg of dexamethasone per day or
- •equivalent doses of other steroid medications) of systemic
- •corticosteroids.
- •8. Patient with any malignancy within 5 years prior to date of
- •randomization, with the exception of adequately treated in situ
- •carcinoma of the cervix uteri, basal or squamous cell carcinoma or
- •nonmelanomatous skin cancer.
- •9. Patient with a known hypersensitivity to any of the study treatment
- •ingredients e.g. to recombinant human antibodies.
- •10. Patient with concurrent serious illnesses, uncontrolled medical
- •conditions, or other medical history including clinically relevant
- •abnormal laboratory results, which in the investigator's opinion would
- •be interfere with a patient's participation in the study, or with the
- •interpretation of study results:
- •a. uncontrolled neurological disease (e.g. recurrent seizures despite
- •existing anticonvulsant therapy);
- •b. neuropathy = grade 1, neuromuscular disease;
- •c. severe disturbance of liver function;
- •d. severe constipation;
- •e. cystitis or other ongoing infections;
- •f. disturbance of micturition;
- •g. severe chronic obstructive pulmonary disease with clinically
- •manifest hypoxemia;
- •h. uncontrolled hypertension (defined as systolic BP > 160 mm Hg or
- •diastolic > 100 mm Hg);
- •i. history of stroke or cerebral ischemia (within 6 months prior to
- •screening);
- •j. history of myocardial infarction or other clinically significant
- •myocardial disease (within 6 months prior to screening) or unstable
- •angina (= NYHA Grade II);
- •k. known infection with HIV or any other severe immunecompromised
- •state according to patient history (if required by local
- •regulations or clinical practice guidelines, patient may be tested during
- 另有 11 项未显示
研究者
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